ALI MEDICOS

Pharmacy STANDARD OPERATING PROCEDURES (SOPs)

The premise of Ali Medicos reflects the professional character of pharmacy and facilitate the
delivery of quality and comprehensive pharmaceutical services by the pharmacist without
compromising his or her professional judgment. This premise was designed and maintained to
meet the patient rights and needs. Moreover, the Pharmacist shall be responsible for the
purchasing, receiving, storage, distribution and disposal of drugs in the Pharmacy.
I. Pharmacy Administration
a. The Pharmacist or the person designated in writing as responsible for the pharmacy is
accountable to the Chief or the executive officer, for properly storing and dispensing
drugs, record keeping, and maintaining a pharmacy policy an procedures manual,
including complaint privacy and security provisions, and ensuring limited access into the
pharmacy during and after hours.
b. The Pharmacist or the person in charge of the pharmacy shall acquire, store, compound,
and dispense medications according to applicable Pharmacy Law and observe the
highest standards of professional practice and established pharmaceutical procedures
to ensure the best possible in patient safety and/or patient medication safety practices.
The Pharmacist or the person in charge of the pharmacy shall ensure adequate current
pharmacy references, hardbound and/or online access.
II. Prescriptions
a. Prescriptions written by Medical/ Dental Practitioners shall be filled and If the medicines
prescribed are not available at the pharmacy, the patient may have the prescription
filled outside of the hospital.
b. Prescriptions shall be personalized. If more than one member of a family is prescribed
the same drug, a separate prescription blank must be used for each member.
c. Pharmacy staff shall write the filled prescription details such as manufacturer's name,
lot number, and expiration date in the record book.
III. Dispensing
a. The pharmacy shall serve as the source of supply of required pharmaceuticals and
related supplies. In addition, the pharmacy dispenses required, authorized preparations
directly to patients.
b. Except for OTC program items, the pharmacy shall dispense all stocked items only on
receiving a properly written, verified prescription. If pharmacy staff receive an illegible
prescription or question its authenticity, dosage, compatibility, or directions to the
patient, staff shall obtain clarification from the prescriber before dispensing the
medication(s).
 c. This hospital shall have a system (computerized, written, etc.) in place to ensure they
can obtain prescriptions in case of a product recall.
d. This hospital shall submit all pertinent patient adverse reactions or product quality
problems to SHCC.
e. When dispensing medication, the dispenser shall identify the patient and ensure his or
her eligibility.
f. In the event of a MEDICATION ERROR (i.e. an error discovered after a prescription has
been dispensed to the patient), a Medication Error Report including pertinent
information relevant to the error (name of discoverer, date of discovery and a brief
statement describing error) shall be completed.
IV. Procurement
a. Only those items that have been licensed and approved by the Food and Drug
Administration (with the exception of vitamins with an established RDA) are authorized
for sale in the Pharmacy.
b. Drugs and other Pharmaceutical products shall be procured from licensed drug
distributors and manufacturers.
c. The procurement process of all medicines should be handled and supervised by a
pharmacist.
d. All purchases should be done through formal Order book, /LPOs signed off by the
pharmacist.
e. All purchases should be received by formal delivery notes clearly detailing; the product
generic name, Brand name, quantity, batch Number, expiry date and other technical
specifications like strength, dosage form etc. All documents used per procurement
should be properly dated, filled, signed, stamped with the pharmacist's stamp bearing
the name and registration number and filed in a box file.
V. Storage
a. In storage, separate external use medications from internal use medications and
ophthalmic and optic preparations.
b. Store flammable drugs according to accepted fire safety regulations.
VI. Pharmacy and Therapeutics Committee
a. The committee is an advisory group on all matters relating to the acquisition and use of
medications. Its recommendations are subject to the approval of the Chief of Hospital or
the Executive Officer.
b. The committee is composed of but not limited to at least one physician, one dentist,
pharmacist and representative from medical administration.
VII. Disposal of materials and equipment
a. Approved Expiry and Near Expiry stickers should be available and used in the manner
stated under standards for storage area.
b. There should be segregated waste bins for biohazard waste, hazardous waste and
nonhazardous labelled in three colors red, yellow and black respectively. For sharps
(bio-hazardous waste), a sharps container should be available.
c. Records should be maintained for disposal of bio-hazardous and hazardous waste and
never destroyed.
d. This Pharmacy shall establish a mechanism of informing clients to return expired drugs,
unused medicines, used drug receptacles (bottles, vials, boxes etc) to the pharmacy
premises.
e. Pharmaceutical waste should be clearly identified and separated from usable stock.
f. The pharmacist should ensure that all the existing legal and professional requirements
with respect to the disposal of pharmaceutical waste are met.
g. The pharmacist should ensure that the relevant documentation is completed and
complies with legal and professional requirements.
VIII. Products Complaint Handling
a. The responsibilities defined in the standards SHOULD be complied with at all times.
b. The Hospital Pharmacy complaints policy which should be reviewed from time to time.
All complaints-oral or written- must be immediately addressed by the pharmacist, and
suitable action be taken to amend the situation.
c. The complaint, its nature, the person’s name and the action taken must be documented
in a complaint register.
d. The event should be reviewed and evaluated to find the underlying cause(s).
Appropriate steps should be taken to amend the operating procedures or other
guidelines so as to prevent the recurrence of the same or similar events.
IX. Drug Recall
a. The Pharmacist should have a well-documented recall policy.
b. The pharmacy should proactively participate in any state wide or nationwide recall
process for any substandard drug. All such records should be initiated upon receiving
authentic information and alarms to do so. The initiation, progress and completion of
recall should be well documented.
c. Adequate vigilance must be maintained to look out for recall alarms from regulatory
sources as well as from pharmaceutical companies.
d. In case of any suspicion, the pharmacist should take immediate steps to stop the sale of
drug and notify the relevant parties.
e. If the pharmacist has a suspicion or a reason to believe that short comings have
occurred in the process of delivery of medicines from the pharmacy, immediate
 effective measures should be initiated to minimize the risk of damage or danger to the
patient(s).
XI. Cold Chain Management
a. The Pharmacist and Pharmacy staff shall ensure that the vaccines they dispense have
been correctly stored.
b. The refrigerator for storage of biologicals should be specifically designed for this
purpose and should have a lock.
c. Vaccines are sensitive biological products; protection of vaccine potency and stability is
important.
d. All biological products freeze at temperatures below 0°C; products that have been
exposed to temperatures below 0°C should not be used.
e. A temperature monitoring system shall be placed in the refrigerator and calibrated from
time to time.
f. A cool pack/ box must be used in transporting biologicals.
g. All acquired biologicals shall be recorded properly by the Pharmacist or the Pharmacy
staff.
Xli. Adverse Drug Reaction
a. The Pharmacist shall outline a step by step approach for employing the spontaneous
reporting of adverse drug reactions in monitoring medicines safety for use.
b. In case of ADRs reported by patients, the Pharmacist shall fill out the reporting form and
submit it to SHCC.
c. The reporting farm should be simple and easy to complete. The reporting form should
not request too much information, particularly information that is difficult to find and
record, or information that is unlikely to be used.
d. The reporting form should have sufficient space in which to describe the suspected
reaction(s). The form should carry a statement reassuring confidentiality of information
given.
e. The reports should be stored securely to maintain privacy. Report shall include essential
data elements, details of medicines, reaction details, reporter details, advice to reporter
and report follow up.